Detection of Brown Adipose Tissue by Magnetic Resonance Imaging

Obesity Clinical Trial

— BAT_PET/MRI  

Official title:

Assessment of MRI Accuracy for the Detection of Brown Adipose Tissue Using 18F-2-fluoro-2-deoxy-D-glucose Fluorodeoxyglucose -PET as a Gold Standard

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02237872
• Other study ID #: 14-1980
• Status: Recruiting
• Start date: September 2014
• Est. completion date: October 2025

Study information

• Verified date: July 2023
• Source: University of North Carolina, Chapel Hill
• Contact: Kristine Baluyot
• Phone: (919) 843-5420
• Email: kristine_baluyot[@]med.unc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The primary goal of this study is to assess the accuracy of conventional fat fraction proton MRI for the detection of Brown Adipose Tissue (BAT) in healthy subjects using 18F-2-fluoro-2-deoxy-D-glucosefluorodeoxyglucose -PET as gold standard.

In this pilot study, MRI and PET imaging of BAT of healthy adult volunteers will be performed on a combined PET/MRI scanner under mild cold condition.

Description:

In the fight against obesity, brown adipose tissue (BAT) is considered to be the newest target. The hypothesis is that this tissue is partially responsible for the imbalance between energy intake and energy expenditure that keeps lean people lean and obese people obese.

The detection of this tissue in adult humans represents an unmet need. BAT is difficult to detect and measurements of tissue fat fraction performed by magnetic resonance imaging have been proposed as a mean to differentiate the highly hydrated brown fat from the less hydrated white adipose tissue and from muscle.

To this end, the objective of this study is to assess the accuracy of magnetic resonance fat fraction measurements for the detection of BAT volume in adult humans, while using PET with 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose as gold standard.

For this study subjects will undergo a combined MRI/PET scan. The scans will be done during stimulation of thermogenic activity by mild cold exposure.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: October 2025
• Est. primary completion date: October 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Each subject must be fully informed and have signed consent.

• BMI < 34

• Normal neurological and psychological development / able to give consent

• Willingness to participate in this study

Exclusion Criteria:

• Subjects less than 18 years of age

• Severe claustrophobia

• Women who are pregnant, nursing an infant or planning to become pregnant in the next 30 days

• People who have a condition that makes MRI unsafe for them (for example, cardiac pacemaker, epicardial pacemaker leads, cochlear implants, metal aneurysm clip, iron filings in your eyes or metal halo devices)

• Have had radiation therapy or chemotherapy in the 2 months prior to PET scan

• Subjects are taking medications that may interfere with BAT detection

Related Conditions & MeSH terms

• Obesity

Locations

Country	Name	City	State
United States	Biomedical Research Imaging Center	Chapel Hill	North Carolina
United States	Biomedical Research Imaging Center	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	North Carolina Translational and Clinical Sciences Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average dice similarity coefficient	The average dice similarity coefficient will be measured to assess the overlap between MRI and PET maps	Up to 1 year after the imaging scan